漫天的繁星 掩藏我点点点的秘密
夏日的蝉鸣 吟唱我对未来的希冀

Salary Profiles in Pharmaceutical Enterprises in China

Yakima阅读(377)

China is a big country, but salary profiles in pharmaceutical enterprises do not differ much from province to province and from city to city.

For new graduates of bachelor’s degree, the salary profiles can be concluded as:

  • 2000~2500 yuan RMB per month in Liaoning Province;
  • 2500~3000 yuan RMB per month in Jiangsu Provinces and Zhejiang Provinces;
  • 3000~3500 yuan RMB per month in Guangdong Province.

I do not know the salary profiles in other places in China. But I think the salary profiles in the above places are representative, because most of pharmaceutical enterprises in China are located in these places. For our convenience in the following text, we now assume that the salary for a new graduate of bachelor’s degree is 3000 yuan RMB per month.

To be honest, as a starting salary, 3000 yuan RMB per month seems very common, not low at all. The problem is, if you are not going to be a department leader, your salary will grow very slowly. It is a common case that if you do not skip to other enterprises, you salary will not grow to 4000 yuan RMB per month with three years’ work experience. If you are willing to skip to another pharmaceutical enterprise with a three years’ work experience, you can hope for a salary of 4000 yuan RMB per month – it will not be too hard to apply for a 4000 yuan RMB salary, however, it will be hard for you to get a work with salary higher than 5000 yuan RMB per month if you are not willing to be a department leader. This is because, 3000 yuan RMB guys are already competent enough for most work in pharmaceutical enterprises in China, 4000 yuan RMB guys can be called elites in pharmaceutical enterprises, and salary higher than 5000 yuan RMB per month is designated for department leaders.

As just said above, if you choose not to skip to another pharmaceutical enterprise, it will be hard for you with three years’ work experience to apply for a salary of 4000 yuan RMB per month, this is because the work you do is so simple that it is hard for you to demonstrate your ability. A pharmaceutical enterprise is a big system, staff in it are just like screws in a machine, you can always be substituted very easily. Therefore you know, most people are able to replace your position in a pharmaceutical company, which demonstrates that your work is very easy in some points. Not only you but also your company want you to be a staff of good ability, when your ability has nothing to do with your salary. Your ability becomes not so necessary, however, when it relates to your salary.

In many opinion, the basic salary profiles are determined by the supply and demand ratio of human resource of basic ability. The salary zone (elite salary zone) above the basic salary is determined by the supply and demand ratio of human resource of elites. Your ability determines your salary position in the salary zone above the basic salary. And there is a high salary zone above the elite salary zone. The high salary zone is for department leaders. There is a blank zone between the high salary zone and the elite salary zone. The blank zone is used to differentiate ordinary staff and leader staff in pharmaceutical enterprises.

Chinese pharmaceutical enterprises are still very young, for example, there are many pharmaceutical enterprises with history of only about 20 years. And you should know, although the turnover of young human resource is not low in pharmaceutical enterprises, the turnover of already-married human resource is actually very low. This is to say, that the turnover of leaders in pharmaceutical enterprises is quite low. However, leaders play important role in team building. A reasonable turnover value is quite important. Neither a too low or too high turnover value is appropriate.

国内外药政机构网址杂烩

Yakima阅读(715)

Updated on June 3, 2015, by Yakima Teng

亚洲 – 中国 – 台湾

非洲 – Tanzania(坦桑尼亚,东非国家)

欧洲 – 乌克兰

南美

【Note】If you want to share this page with your friends and colleagues, please indicate the weblink so that they are always able to read the updated page.

结合注册工作对ERP进行的一个需求分析

Yakima阅读(659)

本文不涉及需要保密的信息,因此我直接放在博客上了,这不是我工作期间写的东西,也没人要求我写,是我自己下班后自己主动写的。因此,本文归属权在我自己,不在公司。写本文是希望日后如果有人对药企ERP感兴趣,可以参考下本文,如能提出不足之处或完善本文,当然更是感激不尽。

注册认证部内部分为两大块的工作,一部分同事负责国外注册,一部分同事负责认证。本人仅就国外注册工作,分析一下需求。

写在前面:

信息有这么些特点:1、载体依附性;2、价值相对性;3、时效性;4、共享性;5、真伪性;6、可处理性;7、传递性。
1、载体依附性。主要就是要注意文件的备份工作。即便是日后有了这么一个文件共享平台,可预见的,它也是要依靠网络才能工作的。所以本部门内部也应定期对文件进行存档。

2、价值相对性。同样一段文字,不同人的解读可能是不一样的,因为解读是带有个人理解和情感色彩的。中国有个“耳语传话”的游戏,可能很多人都做过这个游戏——就是让A将某条信息转述给B,B再转述给C,C再转述给D……依次类推,转述几次之后的信息跟一开始想表达的信息相比,经常会发生信息的丢失和变样,多次转述之后的信息价值已经不大了——“道听途书”说的就是这么个事情。所以如果我们将某些中文翻译成英文后,请尽量保留原来的中文,以便后来的人能准确把握原文的意思。如果是对着纸质文件翻译的,请尽量把纸质文件扫描一下存储在PC里。为尽量保留优质信息,少保留那些用处不大的信息垃圾,应尽量减少信息传达路径上的节点数

3、时效性。法规、SOP文件、市场调研资料等都具有非常明显的时效性,在处理这类文件时一定要标记下诸如版本号、日期等信息。即便是对时效性不那么明显的文件,也应养成随手标记日期的习惯。但是切记,不要采用在文件名上标注“最新”、“今天”这样方式。因为你今天在一个文件名上标记“最新”,一年后这个文件名上还是有个“最新”在那里,但这文件已经一点都不新了。“版本控制”这个话题在此暂不讨论。

4、共享性。这个平台就是为了信息共享,提高效率,减少错误而建。我们部门内部的信息共享也不足,这点我做得不好,以后会注意。但是既然谈到文件的共享,也无法避免“权限分配”这个话题,但是我们暂时不讨论这个话题。另外,文档的管理显然也是个必须谈及的话题,笔者将会另外就此话题写一篇文章。

5、真伪性。我们上网搜出来的化学名,如果是在一些非官方和权威网站上看到的,就需要自己结合化合物的结构式对化学名进行一个基本的判断,网上错的有很多。另,像中国化工网、爱化学等网站,并不是什么权威网站!做MSDS的时候尤其要注意。

6、可处理性。希望不仅要可处理,还要方便处理。我们应统一使用相同版本的办公软件(比如MS Office 2010),并且部门内部同类型文件应采用相同的页边距、合理的框架,这样可以在很大程度上避免同一个文档在不同人的电脑上打开后出现不同面貌的情况,可以节省很多不必要的排版时间。大哥,现在已经2015年了,12年前诞生的MS Office 2003,您就放手吧,扔了吧,别当别人发了个.docx文档给你,你还要别人转下格式重新发给你,你不知道MS Office 2010的办公效率比MS Office 2003高了不是一星半点吗?如果你只是单纯打打字,不用排版什么的,我还是建议你扔掉MS Office 2003,大哥,您可以考虑下Windows系统自带的记事本程序,真的!还有个问题我非常想吐槽,大哥,您见过哪本书的正文是从第二页或者第三页开始的吗,再看看您自己写出来的Word文件,您有分节过吗,您是把封面算作第一页了吗?

7、传递性。信息可以传递。而且有些信息的传递应具有方向性,如果A负责文件的版本控制,B负责将新版本文件及时(不是定期)提交给C,在这种情况下,如果A负责的文件并不是按一定周期定期更新的,那么倒过来由C向B要新文件然后B再向A要新文件的流程就是不及时、低效、容易出错的——因为C/B怎么会知道A那边什么时候更新文件?让C/B每天/周去问A某文件是否有更新现实吗,你是C/B你不烦吗,你是A你不烦吗?这种流程就必须正向进行,当A更新文件后,A应及时主动通知B,然后B接到A的通知后也应及时主动通知C。这种流程中如果存在逆向反馈的需求,比如A需要知道B是将新版本文件给了C还是D或者F,那么B就应在告知C的同时将他告“知了C”这一事实反馈给A。

下面提到的需求,很多都是对应一些文件的。更新文件、文字的人,应在更新的时候备注上更新者的姓名、部门和办公室内线。如果你去找资料,一篇有作者姓名,一篇没有作者姓名,大部分情况下你会觉得前者更有可能会比较可靠。这不是没有道理的,如果文字/文章的更新者被要求备注上自己的姓名,他会对他更新的文字/文章更负责,而且反过来,他认真处理了文字/文章后,他会觉得自己写的东西好,他也会更希望备注上自己的名字,另外,有名字会有存在感不是吗?我自己在博客上写了什么我觉得好的文章,或者我觉得篇幅比较长的文章,我一般都很难忘记一件事——去备注上自己的姓名,来告诉别人这个东西是我写出来的。那么为什么要备注部门和办公室内线呢?毫无以为是为了联系的需要。但为什么要联系呢?主要是因为有些人的书面逻辑表达能力是比较差的,他很有可能写出一段别人不能理解的话或者写出一段让人觉得有歧义的话,即便是对书面逻辑表达能力比较好的人而言,发生这样的事情都是无法避免的,只是频率上的差异而已,这种时候,如果有人要用到这些文字/文件,他就应该通过备注的联系方式来联系这个署名的人来了解确切/正确的意思,个人电话是私人信息,不可强制要求进行备注,而且人员也是会流动的,所以应备注的是办公室内线,备注部门,一是会让信息提供者觉得自己是在为部门工作,而是会让他觉得自己是个有“身份”的人,三是如果整个部门调换了办公室,原来电话失效时,还可以通过部门信息来找到需要找的人。备注上部门后,也能促进部门更新文件的主动性,能较大程度上避免发生诸如“A部门说这些文字/文件的更新是B部门的事情,B部门说是A部门的事情”这样的事。

另,这里提出的需求都是建立在比较理想的情况下的。但是谁都知道,每个药厂都有很多历史遗留问题,在这些问题解决之前,可能很多文字/文件不能像下面所写的那样理想化的提供出来。因此,我的建议是先从正规文字/文件着手,先从情况较为简单、较新的车间开始着手……简言之,先易后难,逐步实施。

另again,这个平台上务必需要一个反馈渠道。

另again and again,可以让各部门领导委派1~3人组件本部门小组,然后各部门小组的人一起实施、讨论、完善这个平台。

另again and again and again,实施、讨论、完善这个平台的人群必须是一个主要(不是全部)由年轻人构成的群体。

另again and again and again and again,没有各部门领导的支持是万万不行的:)

需求1:公司类文件

各部门人数:这个当然不是实时更新,采用定期更新,比如每半年更新一次。

公司的一些财务信息:由于我们不是上市公司,所以很多信息不用向外界公布,但是我们的母公司普洛药业是上市公司,所以诸如主营业务收入、净利润什么的,在普洛药业的年度报告上都是可以查到的,但很多人不知道这件事。我觉得可以以链接的形式在公司内部网站上建立一个指向巨潮资讯网的链接(因为普洛药业的财务信息是在巨潮资讯网上进行披露的)。这样就无需由谁来负责更新信息了,也不会造成泄漏不该泄漏的财务信息的问题,毕竟财务对每个公司而言都是敏感话题。

组织机构图:公司整体的组织机构图及各主要部门(尤其是质量部)的组织机构图。这些东西是有版本的,更新的人需要备注上更新者的姓名、部门和办公室内线。

平面图:公司平面图、质量部平面图、质量保证部平面图、车间平面图(就是那些挂在各部门墙上的那种平面示意图,不是具体的车间设备平面图)

公告信息:虽然注册部是人手一个OA账号,但是其他很多部门的很多一线员工是没有OA账号的。我不是说要把什么办事流程弄进来。我的意思是,像一些公告,比如公司内部招聘信息、年轻人的活动信息等,可以考虑一下。

产品信息:公司经常会上新的产品,而且有些旧产品即使已经停产了也未必就不会重新开工生产,所以

部门/岗位职责、位置:很多人觉得注册认证部是负责国内注册/申报或者主要是负责国内注册/申报的,很多人不知道开发部是做什么事情的,很多人不知道采购部在哪里。

通讯录/QQ群:公司OA上的通讯录我一直不知道更新的频率怎么样,但貌似在上面找到的手机号拨打过去都能打通。但暂时不提这个,因为在这个平台上的许多人是没有OA账号的,所以如果这个平台能有个各部门主要人员通讯录,对这些人是比较有好处的。

其他信息:如公司获得的荣誉、不同厂区的占地面积、绿化率之类的。我们提交的注册申报资料都涉及对公司的介绍,能往好了写当然是最好的:)

需求2:物料控制类文件

物料(包括起始物料、中间体、原料药成品、制剂所用辅料、制剂成品及其他物料)的质量标准与检验方法操作规程文件。

起始物料的供应商信息(公司名、地址等)、起始物料的合成工艺(包含使用的溶剂与试剂,用以分析杂质情况)

需求3:工艺类文件

中间体、原料药成品、制剂成品的工艺规程(流程图、工艺简述等内容从这里面可以获得)

工艺规程文件,有些车间会让我们去质量部拿,两边的文件其实是一模一样的,我觉得这种文件肯定是要从车间拿的,因为车间对工艺熟,问工艺的某些问题肯定是要问车间的,所以文件也要从车间拿。

需求4:分析方法验证/确认类资料

主要是质量研究部的一些资料

需求5:化验报告单

注册部同事从销售服务部弄来连续3批商业批次某产品的化验报告单的时候,应进行上传。

对某一产品的新工艺做验证的时候,三批产品的各种质量标准的报告单在QA存档前都应将扫描件上传共享,因为这些东西在注册的时候是会用到的。(尤其是在产品市场不大,尚未生产商业批的情况下)

需求6:各种SOP文件

我们经常会碰到各种国外的客户问卷,而且其中有很多问卷都明确要求由QA人员填写的。处理这些国外客户的问卷,需要我们对相关的SOP较为熟悉才可以,所以我们有阅读SOP文件的硬需求。但是一方面,SOP文件经常会更新,另一方面,进出口从客户拿接收来问卷的频率是很高的,我们需要保证我们参阅的SOP文件都是最新的。

需求7:经验性文档的编写

一个有经验的人换岗/辞职后,他的许多工作经验也就跟着离开了原先的部门。如果各部门把一些经验性的信息写成文件上传共享,可以迅速提高新人的经验。虽然亲身经历与否给人的感觉也许是很不同的,但必须承认,有很多经验是可以通过阅读而获取的。

需求8:交流平台这段文字是题外话,以后有空另起一个话题(我会关注的人)写

我虽然有时候看起来淡定、呆板、腼腆、孤独,有时候看起来开放、活跃、有个性,但总体来说,我喜欢用“有精英意识的年轻人”来自我评价。我也同样非常希望能碰到其他的“有精英意识的年轻人”。

但实际工作中我接触的年轻人都很少,很多质量部的人根本就没有一点接触。

我刚来公司的时候,室友是个除了吃饭、上班、睡觉,就几乎一直在玩英雄联盟的人。那时候感觉非常孤单(因为工作接触的同龄很少),我就去打羽毛球,结果那时公司里打羽毛球基本都是那些长辈,我就开始找社会上不认识的人打球,并一直不断怂恿公司里新认识的人去打球,基本上能拉去打球的同龄人我都和他们交了朋友,我现在的朋友也主要是这些球友。

我喜欢阅读、喜欢码字(写自己想写的东西,我写上万字也不会觉得累,反而会很兴奋,只是需要的时间会比较长,可能需要一整天,因为我并不想写出来的是一堆我自己都觉得是垃圾的文字)、喜欢讲授(让我上台讲我准备过的、想讲的东西,我可以讲得非常好)、但不喜欢从众。

需求汇总

先不写了。

USP目录结构介绍11:Glossary

Yakima阅读(718)

十一、Glossary(术语)部分下按字母A→Z顺序编排了术语集释,具体如下:

Accurately Weighed

Aerosol

Apparatus 1

Apparatus 2

Capsules

Creams

Emulsions

Foams

Gels

Granules

Implants

Inhalation Aerosol

Inserts

Lotions

Lozenges

Medical Gases

Medicated Gums

Medicated Soaps and Shampoos

Metered-dose Inhaler

Ointments

Pastes

Pellets

Pills

Plasters

Powders

Sprays

Suppositories

Suspensions

Tablets

Tapes

Transdermal Systems

USP目录结构介绍10:Chromatographic Columns

Yakima阅读(788)

十、Chromatographic Columns(色谱柱)部分下含以下内容:

/《Notice》

/《USP Products and Programs for Quality Assurance》

/《Preface》

/《Disclaimers》

 

/General Chapters下含:

/《89 ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING》

/《207 TEST FOR 1,6-ANHYDRO DERIVATIVE FOR ENOXAPARIN SODIUM》

/《223 DIMETHYLANILINE》

/《227 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS》

/《341 ANTIMICROBIAL AGENTS–CONTENT》

/《345 ASSAY FOR CITRIC ACID/CITRATE AND PHOSPHATE》

/《365 BIOTIN ASSAY》

/《401 FATS AND FIXED OILS》

/《411 FOLIC ACID ASSAY》

/《467 RESIDUAL SOLVENTS》

/《469 ETHYLENE GLYCOL, DIETHYLENE GLYCOL, AND TRIETHYLENE GLYCOL IN ETHOXYLATED SUBSTANCES》

/《475 PENICILLIN G DETERMINATION》

/《551 ALPHA TOCOPHEROL ASSAY》

/《571 VITAMIN A ASSAY》

/《581 VITAMIN D ASSAY》

/《611 ALCOHOL DETERMINATION》

 

/按字母A→Z顺序编排的内容。

 

/Packings(填料),下含以下文章:

L1

L10

L11

L12

L13

L14

L15

L16

L17

L18

L19

L2

L20

L21

L22

L23

L24

L25

L26

L27

L28

L29

L3

L30

L31

L32

L33

L34

L35

L36

L37

L38

L39

L4

L40

L41

L42

L43

L44

L45

L46

L47

L48

L49

L50

L51

L52

L53

L54

L55

L56

L57

L58

L59

L6

L60

L61

L62

L63

L64

L65

L66

L67

L68

L69

L7

L70

L71

L72

L73

L74

L75

L76

L77

L78

L79

L8

L80

L81

L82

L83

L84

L85

L86

L9

 

/GC Phases,下含以下文章:

G1

G10

G11

G12

G13

G14

G15

G16

G17

G18

G19

G2

G20

G21

G22

G23

G24

G25

G26

G27

G28

G29

G3

G30

G31

G32

G33

G34

G35

G36

G37

G38

G39

G4

G40

G41

G42

G43

G44

G45

G46

G47

G48

G49

G5

G6

G7

G8

G9

 

/Supports,下含以下文章:

S10

S11

S12

S1A

S1AB

S1C

S1D

S1NS

S2

S3

S4

S5

S6

S7

S8

S9

USP目录结构介绍9:USP Monographs

Yakima阅读(770)

九、USP Monographs(美国药典各论)部分下为按字母A→Z顺序编排的美国药典所收录产品的质量标准。

USP目录结构介绍8:NF Monographs

Yakima阅读(735)

八、NF Monographs(国家处方集各论)部分下为按字母A→Z顺序编排的(美国)国家处方集所收录产品的质量标准。

USP目录结构介绍6:Reference Tables

Yakima阅读(837)

六、Reference Tablets(参考表)部分有以下内容:

/《Containers for Dispensing Capsules and Tablets》

/Description and Solubility,其下有以下文章和目录:

/《Description and Solubility》

 

/Description and Solubility – A

/Description and Solubility – B

/Description and Solubility – C

/Description and Solubility – D

/Description and Solubility – E

/Description and Solubility – F

/Description and Solubility – G

/Description and Solubility – H

/Description and Solubility – I

/Description and Solubility – J

/Description and Solubility – K

/Description and Solubility – L

/Description and Solubility – M

/Description and Solubility – N

/Description and Solubility – O

/Description and Solubility – P

/Description and Solubility – Q

/Description and Solubility – R

/Description and Solubility – S

/Description and Solubility – T

/Description and Solubility – U

/Description and Solubility – V

/Description and Solubility – W

/Description and Solubility – X

/Description and Solubility – Y

/Description and Solubility – Z

 

/《SOLUBILITIES》

/《ATOMIC WEIGHTS》

/《Relative Atomic Masses and Half-Lives of Selected Radionuclides ( 1998 IUPAC).》

/《ALCOHOLOMETRIC TABLE》

/《INTRINSIC VISCOSITY TABLE》

/《THERMOMETRIC EQUIVALENTS》

USP目录结构介绍5:Reagents

Yakima阅读(717)

五、Reagents(试剂)部分下有三个栏目:

栏目一:Reagents, Indicators and Solutions。其下有以下内容:

/《Reagents, Indicators, and Solutions》

/《Reagents》

/Reagent Specifications/(这里是按字母A→Z顺序编排的各个试剂的质量标准)

 

栏目二:Indicators and Indicator Test Papers。其下有以下文章:

/《Indicators》

/《Indicator and Test Papers》

 

栏目三:Solutions。其下有以下文章:

/《Buffer Solutions》

/《Colorimetric Solutions (CS) 》

/《Indicator Solutions》

/《Test Solutions》

/《Volumetric Solutions》

/《Chrom Reagents》

USP目录结构介绍4:Dietary Supplements Chapters

Yakima阅读(738)

四、Dietary Supplements Chapters(膳食补充剂通则)部分有以下文章:

/《<2021> MICROBIAL ENUMERATION TESTS-NUTRITIONAL AND DIETARY SUPPLEMENTS》

/《<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS-NUTRITIONAL AND DIETARY SUPPLEMENTS》

/《<2023> MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE NUTRITIONAL AND DIETARY SUPPLEMENTS》

/《<2030> SUPPLEMENTAL INFORMATION FOR ARTICLES OF BOTANICAL ORIGIN》

/《<2040> DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS》

/《<2091> WEIGHT VARIATION OF DIETARY SUPPLEMENTS》

/《<2232> ELEMENTAL CONTAMINANTS IN DIETARY SUPPLEMENTS》

/《<2750> MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS》

USP目录结构介绍3:General Chapters

Yakima阅读(742)

三、General Chapters(通则)部分结构如下:

General Chapters/Chapter Charts/《USP General Chapters – Chart Guide》

通则/图表章节/《USP总章-图表指南》

General Chapters/Chapter Charts/《Noncomplex Active Drug Substances》

通则/图表章节/《不复杂的活性药物》

General Chapters/Chapter Charts/《Biotechnology-Derived Drug Substances》

通则/图表章节/《》

General Chapters/Chapter Charts/《Excipients》

通则/图表章节/《》

General Chapters/Chapter Charts/《Noncomplex Active Drug Products》

通则/图表章节/《》

General Chapters/Chapter Charts/《Biotechnology-Derived Drug Products》

通则/图表章节/《》

General Chapters/Chapter Charts/《Vaccines》

通则/图表章节/《》

General Chapters/Chapter Charts/《Blood and Blood Products》

通则/图表章节/《》

General Chapters/Chapter Charts/《Cell, Gene, and Tissue Based Products》

通则/图表章节/《》

General Chapters/Chapter Charts/《Drug Product Distribution》

通则/图表章节/《》

General Chapters/Chapter Charts/《Microbiology》

通则/图表章节/《》

General Chapters/Chapter Charts/《Dietary Supplement Ingredients》

通则/图表章节/《》

General Chapters/Chapter Charts/《Dietary Supplement Products》

通则/图表章节/《》

General Chapters/Chapter Charts/《Compounding – Substance/Preparation/Practice》

通则/图表章节/《》

 

General Chapters/General Tests and Assays/《<1> INJECTIONS》

General Chapters/General Tests and Assays/《<2> ORAL DRUG PRODUCTS-PRODUCT QUALITY TESTS》

General Chapters/General Tests and Assays/《<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS-PRODUCT QUALITY TESTS》

General Chapters/General Tests and Assays/《<5> INHALATION AND NASAL DRUG PRODUCTS-GENERAL INFORMATION AND PRODUCT QUALITY TESTS》

General Chapters/General Tests and Assays/《<11> USP REFERENCE STANDARDS》

 

General Chapters/General Tests and Assays/Apparatus for Tests and Asssays/《<17> PRESCRIPTION CONTAINER LABELING》

General Chapters/General Tests and Assays/Apparatus for Tests and Asssays/《<21> THERMOMETERS》

General Chapters/General Tests and Assays/Apparatus for Tests and Asssays/《<31> VOLUMETRIC APPARATUS》

General Chapters/General Tests and Assays/Apparatus for Tests and Asssays/《<41> BALANCES》

 

General Chapters/General Tests and Assays/Microbiological Tests/《<51> ANTIMICROBIAL EFFECTIVENESS TESTING》

General Chapters/General Tests and Assays/Microbiological Tests/《<55> BIOLOGICAL INDICATORS-RESISTANCE PERFORMANCE TESTS》

General Chapters/General Tests and Assays/Microbiological Tests/《<61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS》

General Chapters/General Tests and Assays/Microbiological Tests/《<62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS》

General Chapters/General Tests and Assays/Microbiological Tests/《<63> MYCOPLASMA TESTS》

General Chapters/General Tests and Assays/Microbiological Tests/《<71> STERILITY TESTS》

 

General Chapters/General Tests and Assays/Biological Tests and Assays/《<81> ANTIBIOTICS-MICROBIAL ASSAYS》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<85> BACTERIAL ENDOTOXINS TEST》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<87> BIOLOGICAL REACTIVITY TESTS, IN VITRO》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<88> BIOLOGICAL REACTIVITY TESTS, IN VIVO》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<90> FETAL BOVINE SERUM-QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<91> CALCIUM PANTOTHENATE ASSAY》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<92> GROWTH FACTORS AND CYTOKINES USED IN CELL THERAPY MANUFACTURING》

General Chapters/General Tests and Assays/Biological Tests and Assays/<111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS/《<111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS》

General Chapters/General Tests and Assays/Biological Tests and Assays/《Steps Preceding the Calculation of Potency》

General Chapters/General Tests and Assays/Biological Tests and Assays/《Calculation of Potency from a Single Assay》

General Chapters/General Tests and Assays/Biological Tests and Assays/《Experimental Error and Tests of Assay Validity》

General Chapters/General Tests and Assays/Biological Tests and Assays/《The Confidence Interval and Limits of Potency》

General Chapters/General Tests and Assays/Biological Tests and Assays/《Combination of Independent Assays》

General Chapters/General Tests and Assays/Biological Tests and Assays/《Joint Assay of Several Preparations》

General Chapters/General Tests and Assays/Biological Tests and Assays/《GLOSSARY》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<115> DEXPANTHENOL ASSAY》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<121> INSULIN ASSAYS》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<121.1> PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<123> GLUCAGON BIOIDENTITY TESTS》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<130> PROTEIN A QUALITY ATTRIBUTES》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<151> PYROGEN TEST》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<161> TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES》

General Chapters/General Tests and Assays/Biological Tests and Assays/《<171> VITAMIN B12 ACTIVITY ASSAY》

 

General Chapters/General Tests and Assays/Chemical Tests and Assays下有三个栏目。

栏目一:Identification Tests

《<181> IDENTIFICATION-ORGANIC NITROGENOUS BASES》

《<191> IDENTIFICATION TESTS-GENERAL》

《<193> IDENTIFICATION-TETRACYCLINES》

《<197> SPECTROPHOTOMETRIC IDENTIFICATION TESTS》

《<201> THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST》

 

栏目二:Limit Tests

《<206> ALUMINUM》

《<207> TEST FOR 1,6-ANHYDRO DERIVATIVE FOR ENOXAPARIN SODIUM》

《<208> ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS》

《<211> ARSENIC》

《<221> CHLORIDE AND SULFATE》

《<223> DIMETHYLANILINE》

《<226> 4-EPIANHYDRO-TETRACYCLINE》

《<228> ETHYLENE OXIDE AND DIOXANE》

《<231> HEAVY METALS》

《<232> ELEMENTAL IMPURITIES-LIMITS》

《<233> ELEMENTAL IMPURITIES-PROCEDURES》

《<241> IRON》

《<251> LEAD》

《<261> MERCURY》

《<267> POROSIMETRY BY MERCURY INTRUSION》

《<268> POROSITY BY NITROGEN ADSORPTION-DESORPTION》

《<271> READILY CARBONIZABLE SUBSTANCES TEST》

《<281> RESIDUE ON IGNITION》

《<291> SELENIUM》

 

栏目三:Other Tests and Assays

/《<301> ACID-NEUTRALIZING CAPACITY》

/《<311> ALGINATES ASSAY》

/《<341> ANTIMICROBIAL AGENTS-CONTENT》

/《<345> ASSAY FOR CITRIC ACID/CITRATE AND PHOSPHATE》

/《<351> ASSAY FOR STEROIDS》

/《<361> BARBITURATE ASSAY》

/《<371> COBALAMIN RADIOTRACER ASSAY》

/《<381> ELASTOMERIC CLOSURES FOR INJECTIONS》

/《<391> EPINEPHRINE ASSAY》

/《<401> FATS AND FIXED OILS》

/《<411> FOLIC ACID ASSAY》

/《<413> IMPURITIES TESTING IN MEDICAL GASES》

/《<415> MEDICAL GASES ASSAY》

/《<425> IODOMETRIC ASSAY-ANTIBIOTICS》

/《<429> LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE》

/《<431> METHOXY DETERMINATION》

/《<441> NIACIN OR NIACINAMIDE ASSAY》

/《<451> NITRITE TITRATION》

/《<461> NITROGEN DETERMINATION》

/《<466> ORDINARY IMPURITIES》

/《<467> RESIDUAL SOLVENTS》

/《<471> OXYGEN FLASK COMBUSTION》

/《<481> RIBOFLAVIN ASSAY》

/《<501> SALTS OF ORGANIC NITROGENOUS BASES》

/《<503> ACETIC ACID IN PEPTIDES》

/《<511> SINGLE-STEROID ASSAY》

/《<525> SULFUR DIOXIDE》

/《<531> THIAMINE ASSAY》

/《<541> TITRIMETRY》

/《<551> VITAMIN E ASSAY》

/《<561> ARTICLES OF BOTANICAL ORIGIN》

/《<563> IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN》

/《<565> BOTANICAL EXTRACTS》

/《<571> VITAMIN A ASSAY》

/《<581> VITAMIN D ASSAY》

/《<591> ZINC DETERMINATION》

 

General Chapters/General Tests and Assays/Physical Tests and Determinations下有以下文章:

/《<601>INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS-PERFORMANCE QUALITY TESTS》

/《<602> PROPELLANTS》

/《<603> TOPICAL AEROSOLS》

/《<604> LEAK RATE》

/《<610> ALTERNATIVE MICROBIOLOGICAL SAMPLING METHODS FOR NONSTERILE INHALED AND NASAL PRODUCTS》

/《<611> ALCOHOL DETERMINATION》

/《<616> BULK DENSITY AND TAPPED DENSITY OF POWDERS》

/《<621> CHROMATOGRAPHY》

/《<631> COLOR AND ACHROMICITY》

/《<641> COMPLETENESS OF SOLUTION》

/《<643> TOTAL ORGANIC CARBON》

/《<645> WATER CONDUCTIVITY》

/《<651> CONGEALING TEMPERATURE》

/《<659> PACKAGING AND STORAGE REQUIREMENTS》

/《<660> CONTAINERS-GLASS》

/《<661> CONTAINERS-PLASTICS》

/《<670> AUXILIARY PACKAGING COMPONENTS》

/《<671> CONTAINERS-PERFORMANCE TESTING》

/《<691> COTTON》

/《<695> CRYSTALLINITY》

/《<696> CHARACTERIZATION OF CRYSTALLINE SOLIDS BY MICROCALORIMETRY AND SOLUTION CALORIMETRY》

/《<698> DELIVERABLE VOLUME》

/《<699> DENSITY OF SOLIDS》

/《<701> DISINTEGRATION》

/《<711> DISSOLUTION》

/《<721> DISTILLING RANGE》

/《<724> DRUG RELEASE》

/《<726> ELECTROPHORESIS (deleted) 》

/《<729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS

/《<730> PLASMA SPECTROCHEMISTRY》

/《<731> LOSS ON DRYING》

/《<733> LOSS ON IGNITION》

/《<735> X-RAY FLUORESCENCE SPECTROMETRY》

/《<736> MASS SPECTROMETRY》

/《<741> MELTING RANGE OR TEMPERATURE》

/《<751> METAL PARTICLES IN OPHTHALMIC OINTMENTS》

/《<755> MINIMUM FILL》

/《<761> NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY》

/《<771> OPHTHALMIC OINTMENTS》

/《<776> OPTICAL MICROSCOPY》

/《<781> OPTICAL ROTATION》

/《<785> OSMOLALITY AND OSMOLARITY》

/《<786> PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING》

/《<787> SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS》

/《<788> PARTICULATE MATTER IN INJECTIONS》

/《<789> PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS》

/《<790> VISIBLE PARTICULATES IN INJECTIONS》

/《<791> pH》

/《<795> PHARMACEUTICAL COMPOUNDING-NONSTERILE PREPARATIONS》

/《<797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS》

/《<801> POLAROGRAPHY》

/《<811> POWDER FINENESS》

/《<821> RADIOACTIVITY》

/《<823> POSITRON EMISSION TOMOGRAPHY DRUGS FOR COMPOUNDING, INVESTIGATIONAL, AND RESEARCH USES》

/《<831> REFRACTIVE INDEX》

/《<841> SPECIFIC GRAVITY》

/《<846> SPECIFIC SURFACE AREA》

/《<851> SPECTROPHOTOMETRY AND LIGHT-SCATTERING》

/《<861> SUTURES-DIAMETER》

/《<871> SUTURES-NEEDLE ATTACHMENT》

/《<881> TENSILE STRENGTH》

/《<891> THERMAL ANALYSI》

/《<905> UNIFORMITY OF DOSAGE UNITS》

/《<911> VISCOSITY-CAPILLARY VISCOMETER METHODS》

/《<912> ROTATIONAL RHEOMETER METHODS》

/《<913> ROLLING BALL VISCOMETER METHOD》

/《<921> WATER DETERMINATION》

/《<941> CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDS BY X-RAY POWDER DIFFRACTION (XRPD)》

 

General Chapters/General Information下有以下文章(含一个1090目录)

/《General Chapters》

/《<1005> ACOUSTIC EMISSION》

/《<1010> ANALYTICAL DATA-INTERPRETATION AND TREATMENT》

/《<1015> AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS》

/《<1024> BOVINE SERUM》

/《<1027> FLOW CYTOMETRY》

/《<1030> BIOLOGICAL ASSAY CHAPTERS-OVERVIEW AND GLOSSARY》

/《<1031> THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS》

/《<1032> DESIGN AND DEVELOPMENT OF BIOLOGICAL ASSAYS》

/《<1033> BIOLOGICAL ASSAY VALIDATION》

/《<1034> ANALYSIS OF BIOLOGICAL ASSAYS》

/《<1035> BIOLOGICAL INDICATORS FOR STERILIZATION》

/《<1041> BIOLOGICS》

/《<1043> ANCILLARY MATERIALS FOR CELL, GENE, AND TISSUE-ENGINEERED PRODUCTS》

/《<1044> CRYOPRESERVATION OF CELLS》

/《<1045> BIOTECHNOLOGY-DERIVED ARTICLES》

/《<1046> CELLULAR AND TISSUE-BASED PRODUCTS》

/《<1047> GENE THERAPY PRODUCTS》

/《<1048> QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS》

/《<1049> QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS》

/《<1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN》

/《<1051> CLEANING GLASS APPARATUS》

/《<1052> BIOTECHNOLOGY-DERIVED ARTICLES-AMINO ACID ANALYSIS》

/《<1053> CAPILLARY ELECTROPHORESIS》

/《<1054> BIOTECHNOLOGY-DERIVED ARTICLES-ISOELECTRIC FOCUSING》

/《<1055> BIOTECHNOLOGY-DERIVED ARTICLES-PEPTIDE MAPPING》

/《<1056> BIOTECHNOLOGY-DERIVED ARTICLES-POLYACRYLAMIDE GEL ELECTROPHORESIS》

/《<1057> BIOTECHNOLOGY-DERIVED ARTICLES-TOTAL PROTEIN ASSAY》

/《<1058> ANALYTICAL INSTRUMENT QUALIFICATION》

/《<1059> EXCIPIENT PERFORMANCE》

/《<1061> COLOR-INSTRUMENTAL MEASUREMENT》

/《<1065> ION CHROMATOGRAPHY》

/《<1066> PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE》

/《<1072> DISINFECTANTS AND ANTISEPTICS》

/《<1074> EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES》

/《<1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS》

/《<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS》

/《<1080> BULK PHARMACEUTICAL EXCIPIENTS-CERTIFICATE OF ANALYSIS》

/《<1081> GEL STRENGTH OF GELATIN》

/《<1084> GLYCOPROTEIN AND GLYCAN ANALYSIS-GENERAL CONSIDERATIONS》

/《<1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS》

/《<1087> APPARENT INTRINSIC DISSOLUTION-DISSOLUTION TESTING PROCEDURES FOR ROTATING DISK AND STATIONARY DISK》

/《<1088> IN VITRO AND IN VIVO EVALUATION OF DOSAGE FORMS》

/<1090> ASSESSMENT OF DRUG PRODUCT PERFORMANCE-BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION/《<1090> ASSESSMENT OF DRUG PRODUCT PERFORMANCE-BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION》

/《BACKGROUND》

/《BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION》

/《DISSOLUTION AND IN VITRO PRODUCT PERFORMANCE》

/《BIOWAIVER》

/《APPENDIX》

/《Endnotes》

/《<1091> LABELING OF INACTIVE INGREDIENTS》

/《<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION》

/《<1094> CAPSULES-DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES》

/《<1097> BULK POWDER SAMPLING PROCEDURES》

/《<1102> IMMUNOLOGICAL TEST METHODS-GENERAL CONSIDERATIONS》

/《<1103> IMMUNOLOGICAL TEST METHODS-ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 》

/《<1104> IMMUNOLOGICAL TEST METHODS-IMMUNOBLOT ANALYSIS》

/《<1105> IMMUNOLOGICAL TEST METHODS-SURFACE PLASMON RESONANCE》

/《<1106> IMMUNOGENICITY ASSAYS-DESIGN AND VALIDATION OF IMMUNOASSAYS TO DETECT ANTI-DRUG ANTIBODIES》

/《<1111> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE》

/《<1112> APPLICATION OF WATER ACTIVITY DETERMINATION TO NONSTERILE PHARMACEUTICAL PRODUCTS》

/《<1113> MICROBIAL CHARACTERIZATION, IDENTIFICATION, AND STRAIN TYPING》

/《<1116> MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS》

/《<1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES》

/《<1118> MONITORING DEVICES-TIME, TEMPERATURE, AND HUMIDITY》

/《<1119> NEAR-INFRARED SPECTROSCOPY》

/《<1120> RAMAN SPECTROSCOPY》

/《<1121> NOMENCLATURE》

/《<1125> NUCLEIC ACID-BASED TECHNIQUES-GENERAL》

/《<1126> NUCLEIC ACID-BASED TECHNIQUES-EXTRACTION, DETECTION, AND SEQUENCING》

/《<1127> NUCLEIC ACID-BASED TECHNIQUES-AMPLIFICATION》

/《<1128> NUCLEIC ACID-BASED TECHNIQUES-MICROARRAY》

/《<1129> NUCLEIC ACID-BASED TECHNIQUES-GENOTYPING》

/《<1130> NUCLEIC ACID-BASED TECHNIQUES-APPROACHES FOR DETECTING TRACE NUCLEIC ACIDS (RESIDUAL DNA TESTING) 》

/《<1136> PACKAGING AND REPACKAGING-SINGLE-UNIT CONTAINERS》

/《<1151> PHARMACEUTICAL DOSAGE FORMS》

/《<1160> PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING》

/《<1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING》

/《<1171> PHASE-SOLUBILITY ANALYSIS》

/《<1174> POWDER FLOW》

/《<1176> PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS》

/《<1177> GOOD PACKAGING PRACTICES》

/《<1178> GOOD REPACKAGING PRACTICES》

/《<1180> HUMAN PLASMA》

/《<1181> SCANNING ELECTRON MICROSCOPY》

/《<1184> SENSITIZATION TESTING》

/《<1191> STABILITY CONSIDERATIONS IN DISPENSING PRACTICE》

/《<1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS》

/《<1196> PHARMACOPEIAL HARMONIZATION》

/《<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS》

/《<1207> STERILE PRODUCT PACKAGING-INTEGRITY EVALUATION》

/《<1208> STERILITY TESTING-VALIDATION OF ISOLATOR SYSTEMS》

/《<1209> STERILIZATION-CHEMICAL AND PHYSICOCHEMICAL INDICATORS AND INTEGRATORS》

/《<1211> STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES》

/《<1216> TABLET FRIABILITY》

/《<1217> TABLET BREAKING FORCE》

/《<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS-PARAMETRIC RELEASE》

/《<1223> VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS》

/《<1224> TRANSFER OF ANALYTICAL PROCEDURES》

/《<1225> VALIDATION OF COMPENDIAL PROCEDURES》

/《<1226> VERIFICATION OF COMPENDIAL PROCEDURES》

/《<1227> VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES》

/《<1229> STERILIZATION OF COMPENDIAL ARTICLES》

/《<1229.1> STEAM STERILIZATION BY DIRECT CONTACT》

/《<1229.2> MOIST HEAT STERILIZATION OF AQUEOUS LIQUIDS》

/《<1229.3> MONITORING OF BIOBURDEN》

/《<1229.4> STERILIZING FILTRATION OF LIQUIDS》

/《<1229.7> GASEOUS STERILIZATION》

/《<1229.8> DRY HEAT STERILIZATION》

/《<1229.10> RADIATION STERILIZATION》

/《<1230> WATER FOR HEMODIALYSIS APPLICATIONS》

/《<1231> WATER FOR PHARMACEUTICAL PURPOSES》

/《<1235> VACCINES FOR HUMAN USE-GENERAL CONSIDERATIONS》

/《<1237> VIROLOGY TEST METHODS》

/《<1238> VACCINES FOR HUMAN USE-BACTERIAL VACCINES》

/《<1241> WATER-SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS》

/《<1251> WEIGHING ON AN ANALYTICAL BALANCE》

/《<1265> WRITTEN PRESCRIPTION DRUG INFORMATION-GUIDELINES》

/《<1285> PREPARATION OF BIOLOGICAL SPECIMENS FOR HISTOLOGIC AND IMMUNOHISTOCHEMICAL ANALYSIS》

/《<1285.1> HEMATOXYLIN AND EOSIN STAINING OF SECTIONED TISSUE FOR MICROSCOPIC EXAMINATION》

/《<1601> PRODUCTS FOR NEBULIZATION-CHARACTERIZATION TESTS》

/《<1644> THEORY AND PRACTICE OF ELECTRICAL CONDUCTIVITY MEASUREMENTS OF SOLUTIONS》

/《<1660> EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS》

/《<1724> SEMISOLID DRUG PRODUCTS-PERFORMANCE TESTS》

/《<1761> APPLICATIONS OF NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY》

/《<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS》

/《<1911> RHEOMETRY》

USP目录结构介绍2:General Notices

Yakima阅读(781)

二、General Notices(凡例)部分结构如下:

General Notices/USP/《USP》

凡例/美国药典/《美国药典》

General Notices/USP/《1. TITLE AND REVISION》

凡例/美国药典/《1、名称和修订》

General Notices/USP/《2. OFFICIAL STATUS AND LEGAL RECOGNITION》

凡例/美国药典/《2、官方状态和法律认可》

General Notices/USP/《3. CONFORMANCE TO STANDARDS》

凡例/美国药典/《3、标准一致性》

General Notices/USP/《4. MONOGRAPHS AND GENERAL CHAPTERS》

凡例/美国药典/《4、各论和通则》

General Notices/USP/《5. MONOGRAPH COMPONENTS》

凡例/美国药典/《5、专论结构》

General Notices/USP/《6. TESTING PRACTICES AND PROCEDURES》

凡例/美国药典/《6、检测规范和方法》

General Notices/USP/《7. TEST RESULTS》

凡例/美国药典/《7、检测结果》

General Notices/USP/《8. TERMS AND DEFINITIONS》

凡例/美国药典/《8、术语和定义》

General Notices/USP/《9. PRESCRIBING AND DISPENSING》

凡例/美国药典/《9、处方和配药》

General Notices/USP/《10. PRESERVATION, PACKAGING, STORAGE, AND LABELING》

凡例/美国药典/《10、保存、包装、贮藏和贴签》